EczemaPhase 3BAMBOONCT01230190
Management of Eczema by Specific Probiotic Strains
A Phase 3 study testing Ecologic ® Panda II in people with Eczema and Atopic Dermatitis, run by Agentschap NL at 1 site in Netherlands.
Trial summary
To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD in infants aged 0-15 months. The probiotic mixture has been studied in laboratory setting and has proven IL-10 stimulating effects. Read more about this study
- Who is it for?
- Ages 1 day to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Eczema, Atopic Dermatitis
- What is being tested?
- Ecologic ® Panda II
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2011to Jul 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children 0-15 months with mild to moderate eczema (SCORAD score 15-50 or equally EASI score) for at least two weeks
Who cannot join
- use of topical steroids class II or higher (which means treatment for severe eczema),
- use of oral steroids or treatment with antibiotics prior to inclusion.
- severe comorbidity
- lack of knowledge of the Dutch language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beyond Conventional Treatment of Atopic Eczema in Infants: Management By Specific prObiOtic Strains
To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD in infants aged 0-15 months. The probiotic mixture has been studied in laboratory setting and has proven IL-10 stimulating effects. Therefore it is thought to decrease AD severity in young children (beyond the conventional treatment).
Read the detailed description
Atopic dermatitis (AD) is a highly prevalent chronic, itching, inflammatory skin disease that often presents in infancy. The disease can be the first manifestation of the so-called atopic march, the natural progression of allergic disorders, with subsequent development of asthma and allergic rhinitis. Approximately 40% of the children with AD will develop asthma later in childhood.
Currently, topical corticosteroids are the mainstay treatment of atopic dermatitis; however, relapses are common and parents often fear possible side-effects, leading to non-compliance. There is increasing evidence that the intestinal microbiota plays an important role in the development of allergic diseases. Modulation of the intestinal microbiota with probiotics, living micro-organisms with immunomodulatory effects, could possibly offer a new way of treatment of allergic disease.
Clinical trials investigating the preventive as well as therapeutic effect of probiotics on atopic dermatitis show inconsistent results. Systematic (Cochrane) reviews of all clinical trials (about treatment of AD by use of probiotics) concluded that the probiotic strains studied to date are not an effective treatment for AD; however, there is great heterogeneity between studies since many different probiotic strains are used. Because of the known strain specific capacity in immunomodulatory effects, some strains might have a greater effect than others.
Better results can possibly be achieved by using a selected, (in laboratory setting) proven modulatory multispecies probiotic mixture, containing 6 different strains.
- Conditions
- Eczema, Atopic Dermatitis
- Being tested
- Ecologic ® Panda II, placebo
- Keywords
- infants, adaptive immunology, atopic dermatitis, probiotics
- Medical subject headings
- Eczema, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecologic ® Panda IIDietary supplement
Also called multispecies probiotic mixture
Probiotic strains: 3 Bifidobacteria, 3 Lactococci, 1*10^9 Colony Forming Units/g.
Composition: rice starch, maltodextrins, bacterial strains and mix of minerals.
placeboDietary supplement
Also called placebo mixture
rice starch, maltodextrins, and mix of minerals. The placebo mixture is similar in aspect, consistency and taste as Ecologic ® Panda II (intervention).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic mixture | Active comparator | participants daily ingest a selected probiotic mixture for a period of 3 months Receives: Dietary Supplement: Ecologic ® Panda II |
| Placebo mixture | Placebo comparator | controls daily ingest a placebo mixture for a period of 3 months. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in severity of atopic dermatitis
The primary outcome will be measured by change in the severity of AD by using the SCORAD score.
Other outcomes: subjective (parental) change in eczema severity, change in amount of and type of topical steroid use, quality of life during and after intervention (measured by ITQOL questionnaire), amount of respiratory tract infections, use of antibiotics, use of primary care medicine (general practitioner).
All used probiotic strains contain the QPS status. (serious) adverse events will be recorded systematically.
Measured: 6 months
Secondary outcomes (2)
Effects on infant gut microbiota
Analyses will be done by molecular microbiological techniques on feces samples (that will be collected at baseline, and after 1,3 and 6 months after enrollment.
Measured: 6 months
Effects on the immature immune system
These effects will be measured by analyzing serum IgE and different (Th1/Th2) cytokines and chemokines
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startMar 2011
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Why it stopped: Because of safety issues/support concerning the multispecies probiotic mixture
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agentschap NL
- Sponsor type
- Other government
- Investigators
- Arine M Vlieger, MD, PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230190
- Sponsor's protocol ID
- BAMBOO
- Acronym
- BAMBOO
- Status last verified
- Mar 2011
- First submitted
- 28 Oct 2010
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Conventional Treatment of Atopic Eczema in Infants: Management By Specific prObiOtic Strains
- ClinicalTrials.gov ID
- NCT01230190
- Acronym / sponsor ID
- BAMBOO / BAMBOO
- Conditions
- Eczema, Atopic Dermatitis
- Keywords
- infants, adaptive immunology, atopic dermatitis, probiotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of safety issues/support concerning the multispecies probiotic mixture
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Agentschap NLOther government
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 29 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD in infants aged 0-15 months. The probiotic mixture has been studied in laboratory setting and has proven IL-10 stimulating effects. Therefore it is thought to decrease AD severity in young children (beyond the conventional treatment).
Detailed description
Atopic dermatitis (AD) is a highly prevalent chronic, itching, inflammatory skin disease that often presents in infancy. The disease can be the first manifestation of the so-called atopic march, the natural progression of allergic disorders, with subsequent development of asthma and allergic rhinitis. Approximately 40% of the children with AD will develop asthma later in childhood.
Currently, topical corticosteroids are the mainstay treatment of atopic dermatitis; however, relapses are common and parents often fear possible side-effects, leading to non-compliance. There is increasing evidence that the intestinal microbiota plays an important role in the development of allergic diseases. Modulation of the intestinal microbiota with probiotics, living micro-organisms with immunomodulatory effects, could possibly offer a new way of treatment of allergic disease.
Clinical trials investigating the preventive as well as therapeutic effect of probiotics on atopic dermatitis show inconsistent results. Systematic (Cochrane) reviews of all clinical trials (about treatment of AD by use of probiotics) concluded that the probiotic strains studied to date are not an effective treatment for AD; however, there is great heterogeneity between studies since many different probiotic strains are used. Because of the known strain specific capacity in immunomodulatory effects, some strains might have a greater effect than others.
Better results can possibly be achieved by using a selected, (in laboratory setting) proven modulatory multispecies probiotic mixture, containing 6 different strains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic mixture | Active comparator | Dietary Supplement: Ecologic ® Panda IIparticipants daily ingest a selected probiotic mixture for a period of 3 months |
| Placebo mixture | Placebo comparator | Dietary Supplement: placebocontrols daily ingest a placebo mixture for a period of 3 months. |
Who may qualify
- Ages
- 1 day to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children 0-15 months with mild to moderate eczema (SCORAD score 15-50 or equally EASI score) for at least two weeks
Key exclusion criteria (4 listed)
- use of topical steroids class II or higher (which means treatment for severe eczema),
- use of oral steroids or treatment with antibiotics prior to inclusion.
- severe comorbidity
- lack of knowledge of the Dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecologic ® Panda IIAlso: multispecies probiotic mixtureProbiotic strains: 3 Bifidobacteria, 3 Lactococci, 1*10^9 Colony Forming Units/g. Composition: rice starch, maltodextrins, bacterial strains and mix of minerals. | Dietary supplement | Probiotic mixture |
| placeboAlso: placebo mixturerice starch, maltodextrins, and mix of minerals. The placebo mixture is similar in aspect, consistency and taste as Ecologic ® Panda II (intervention). | Dietary supplement | Placebo mixture |
Primary outcome
decrease in severity of atopic dermatitis
Time frame: 6 months
The primary outcome will be measured by change in the severity of AD by using the SCORAD score. Other outcomes: subjective (parental) change in eczema severity, change in amount of and type of topical steroid use, quality of life during and after intervention (measured by ITQOL questionnaire), amount of respiratory tract infections, use of antibiotics, use of primary care medicine (general practitioner). All used probiotic strains contain the QPS status. (serious) adverse events will be recorded systematically.
2 secondary outcomes
Effects on infant gut microbiota
Time frame: 6 months
Effects on the immature immune system
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arine M Vlieger, MD, PhD principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ecologic ® Panda II in people with Eczema and Atopic Dermatitis, run by Agentschap NL at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decrease in severity of atopic dermatitis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.